Surgical implant devices and methods for their manufacture and use

ABSTRACT

A vascular system includes a delivery apparatus and an endovascular device. The delivery apparatus including a catheter and a control lead. The control lead extends through a lumen of the catheter and is configured to be manipulated by a user. The endovascular device is releasably coupled to the delivery apparatus and includes an implant body, a seal extending radially outwardly from the implant body, and one or more tissue engaging elements. The seal is configured to contact native vascular tissue to reduce leakage between the native vascular tissue and the implant body. The tissue engaging elements are pivotable relative to the seal from a compressed state to an expanded state. In the compressed state, the tissue engaging elements are positioned so as to disengage the native vascular tissue. In the expanded state, the tissue engaging elements extend outwardly from the seal and are configured to engage the native vascular tissue.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/934,850, filed Mar. 23, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/213,125, filed Jul. 18, 2016, now U.S. Pat. No.9,925,033, which is a divisional of U.S. patent application Ser. No.12/822,291, filed on Jun. 24, 2010, now U.S. Pat. No. 9,408,607, whichclaims the benefit of U.S. Provisional Application No. 61/222,646, filedon Jul. 2, 2009. The entire disclosures of the related applications areincorporated by reference herein.

FIELD OF THE INVENTION

The present disclosure relates to the field of surgical implant devicesand method for their manufacture and use. In particular, this disclosurerelates to medical devices applicable to vascular surgery and thetreatment of aneurysms or other luminal defects in other anatomicconduits.

BACKGROUND OF THE INVENTION

Medical and surgical implants are often placed in anatomic spaces whereit is desirable for the implant to conform to the unique anatomy of thetargeted anatomic space to secure a seal therein, preferably withoutdisturbing or distorting the unique anatomy of said targeted anatomicspace.

While the lumens of most hollow anatomic spaces are ideally circular, infact the cross-sectional configurations of most anatomic spaces are atbest ovoid, and may be highly irregular. Lumenal irregularity may be dueto anatomic variations and/or to pathologic conditions that may changethe shape and topography of the lumen and its associated anatomic wall.

Examples of anatomic spaces where such implants may be deployed include,but are not limited to, blood vessels, the heart, other vascularstructures, vascular defects, the trachea, the oropharynx, theesophagus, the stomach, the duodenum, the ileum, the jejunum, the colon,the rectum, ureters, urethras, fallopian tubes, biliary ducts,pancreatic ducts, or other anatomic structures containing a lumen usedfor the transport of gases, blood, or other liquids or liquidsuspensions within a mammalian body.

Among vascular effects that are addressed by some preferred embodimentsof the present disclosure are thoracic and abdominal aortic aneurysms.

In order for a patient to be a candidate for existing endograft methodsand technologies, a proximal neck of at least 15 mm of normal aorta mustexist between the origin of the most inferior renal artery and theorigin of the aneurysm in the case of abdominal aneurysms or the leftsubclavian artery for thoracic aortic aneurysms in order to permit anadequate seal. Similarly, at least 15 mm of normal vessel must existdistal to the distal extent of the aneurysm for an adequate seal to beachieved.

Migration of existing endografts has also been a significant clinicalproblem, potentially causing leakage and re-vascularization of aneurysmsand/or compromising necessary vascular supplies to arteries such as thecarotid, subclavian, renal, or internal iliac vessels. This problem hasbeen partially addressed by some existing endograft designs, in whichbarbs or hooks have been incorporated to help retain the endograft atits intended site. However, these existing endograft designs are notremovable and repositionable once they are deployed. Thus, once such anendograft has been placed, open surgery is necessary if there is failuredue to leakage or undesired occlusion of other vascular structures.

Because of the limitations imposed by existing vascular endograftdevices and endovascular techniques, approximately eighty percent ofabdominal and thoracic aneurysms repaired in the U.S. are still managedthough open vascular surgery, instead of the lower morbidity of theendovascular approach.

SUMMARY OF THE INVENTION

Implant devices according to the present disclosure are provided withone or more improvements that increase the ability of such an implant tobe precisely deployed or re-deployed, with better in situ accommodationto the local anatomy of the targeted anatomic site, and/or with theability for post-deployment adjustment to accommodate anatomic changesthat might compromise the efficacy of the implant.

One aspect of the present disclosure is directed towards novel designsfor endovascular implant grafts, and methods for their use for thetreatment of aortic aneurysms and other structural vascular defects. Asealable, repositionable endograft system for placement in a bloodvessel is disclosed, in which an endograft implant comprises anon-elastic tubular implant body with an elastic proximal ends and anelastic distal end(s). Both the elastic proximal and distal ends in animplant according to the present disclosure further comprise one or morecircumferential sealable collars and one or more variable sealingdevice, capable of controllably varying the expanded diameter of saidcollar upon deployment to achieve the desired seal between the collarand the vessel's inner wall. An endovascular implant according to thepresent disclosure further comprises a central lumen and one or morecontrol leads extending distally from releasable connections with eachvariable sealing device. Embodiments of endovascular implants accordingto the present disclosure may further be provided with retractableretention tines or other retention devices allowing an implant to berepositioned before final deployment. An endograft system according tothe present disclosure further comprises a delivery catheter with anoperable tubular sheath, capable of housing a folded or compressedendograft implant prior to deployment and capable of retracting orotherwise opening in at least its proximal end to allow implantdeployment, said sheath sized and configured to allow its placement viaa peripheral arteriotomy site, and of appropriate length to allow itsadvancement into the thoracic or abdominal aorta, as required for aspecific application.

Post-implantation remodeling of the aortic neck proximal to anendovascular graft (endograft) has been reported. While this phenomenonmay be due to aortic wall injury caused by the over-dilatation(typically 110%) of the aorta to deploy the metallic lattice thatsupports such endografts, existing endograft technology does not allowfor the management of this condition without placement of an additionalendograft sleeve to cover the remodeled segment, again requiring theover-dilatation for deployment.

Endografts of the present disclosure do not require balloonover-dilatation for their deployment. Moreover, the improvements inimplant design described herein allow for better accommodation by theimplant of the local anatomy, as opposed to altering the local anatomyto conform to the implant as is the presently accepted practice.Finally, implants with improvements of the present disclosure may beprovided with means to change the implant configuration post-initialdeployment, allowing for manual adaptation to any future anatomicremodeling at the implantation site.

The preceding description is presented only as an exemplary applicationof the devices and methods according to the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an embodiment of an implant interfaceaccording to the present disclosure.

FIG. 1B is a detailed view of an embodiment of an implant interfaceaccording to the present disclosure.

FIG. 2 is a detailed view of an embodiment of an implant interface witha coil spring drive gear design according to the present disclosure.

FIG. 3 is a perspective view of an embodiment of an implant interfacewith an uncompressed spring interposition mechanism according to thepresent disclosure.

FIG. 4 is a perspective view of an embodiment of an implant interfacewith a compressed spring-tine mechanism according to the presentdisclosure.

FIG. 5 is a detailed view of an embodiment of an implant interface withan electromagnetic re-docking mechanism and spring-loaded remodelingattachment members according to the present disclosure.

FIGS. 6A-6D are detailed views of several exemplary embodiments ofspring-loaded remodeling attachment members according to the presentdisclosure.

FIG. 7A is a detailed cross sectional view of an exemplary embodiment ofspring-loaded remodeling attachment member contained within anuncompressed foam gasket according to the present disclosure.

FIG. 7B is a detailed cross sectional view of an exemplary embodiment ofspring-loaded remodeling attachment member deployed into an aortic wallthrough a compressed foam gasket with a spring-loaded remodelingattachment at full tension according to the present disclosure.

FIG. 7C is a detailed cross sectional view of an exemplary embodiment ofspring-loaded remodeling attachment member deployed into an aortic wallthrough a compressed foam gasket with a spring-loaded remodelingattachment at full extension to accommodate aortic remodeling accordingto the present disclosure.

FIGS. 8A-8D are detailed views of several alternate exemplaryembodiments of spring-loaded remodeling attachment members according tothe present disclosure.

FIGS. 9A and 9B are detailed views of another exemplary embodiment ofspring-loaded remodeling attachment members according to the presentdisclosure, in which the band containing attachment members is mountedto a fully compressed spring-tensioned suspension.

FIGS. 10A and 10B are detailed views of the exemplary embodiment ofspring-loaded remodeling attachment members illustrated in FIGS. 9A and9B according to the present disclosure, in which the band containingattachment members is mounted to a nearly fully extendedspring-tensioned suspension.

FIG. 11 is a perspective view of an embodiment of an implant interfacewith circumferential sealable collars and a variable sealing device witha re-docking mechanism according to the present disclosure, with there-docking mechanism not connected to a removable re-docking controllead.

FIG. 12 is a perspective view of an embodiment of an implant interfacewith a circumferential sealable collars and a variable sealing devicewith a re-docking mechanism according to the present disclosure, withthe re-docking mechanism engaged by a removable re-docking control lead.

FIG. 13 is a perspective anatomic view of an embodiment of an endograftimplant according to the present disclosure in which the implantdelivery mechanism is remotely steerable to allow a variable plane ofdelivery for implantation.

FIG. 14 is a perspective anatomic view of the embodiment of an endograftimplant shown in FIG. 13 in which the implant delivery mechanism hasbeen steered to an angular plane of delivery.

FIG. 15 is a perspective anatomic view of the embodiment of an endograftimplant shown in FIG. 14 in which the implant has been sealed anddelivered in a desired angular site and the steering mechanism has beendisengaged from the implant and is being removed through the deliverycatheter.

FIG. 16 shows a perspective anatomic view of an exemplary embodiment ofan endograft implant according to the present disclosure in which theimplant is a universal proximal cuff implant for treatment of anabdominal aortic aneurysm.

FIG. 17 shows a perspective anatomic view of an exemplary embodiment ofan endograft implant according to the present disclosure in which theimplant is a universal proximal cuff implant for treatment of a thoracicaortic aneurysm.

FIG. 18 is an anatomic drawing which shows a complex aortic arch with afirst aneurysm involving the aortic arch and a second aneurysm involvingthe descending aorta.

FIG. 19 shows the anatomic situation of FIG. 18, in which extra-anatomicsurgical bypass has been performed with bypasses between the right andleft carotid and between the left carotid and left subclavian arteries.

FIG. 20 shows the same view as FIG. 19, with exemplary endovascularplacement of three embodiments of endografts of the present disclosureto traverse the pathology and maintain vital circulation.

DETAILED DESCRIPTION OF DISCLOSED EMBODIMENTS

The present disclosure may be understood more readily by reference tothe following detailed description of the preferred embodimentsdescribed herein and the examples included herein. However, before thepreferred embodiments of the devices and methods according to thepresent disclosure are described, it is to be understood that thisdisclosure is not limited to the exemplary embodiments described withinthis disclosure, and the numerous modifications and variations thereinthat will be apparent to those skilled in the art remain within thescope of the disclosure provided herein. It is also to be understoodthat the terminology used herein is for the purpose of describingspecific embodiments only and is not intended to be limiting.

Unless otherwise noted, the terms used herein are to be understoodaccording to conventional usage by those of ordinary skill in therelevant art. In addition to the definitions of terms provided below, itis to be understood that as used in the specification and in the claims,“a” or “an” can mean one or more, depending upon the context in which itis used.

Certain aspects of the present disclosure are directed towards noveldesigns for sealable and repositionable endovascular implant grafts, andmethods for their use for the treatment of aortic aneurysms and otherstructural vascular defects.

In an exemplary embodiment according to the present disclosure, asealable vascular endograft system for placement in a vascular defect isprovided, comprising an elongated main implant delivery catheter with anexternal end and an internal end for placement in a blood vessel withinternal walls. In such an exemplary embodiment, the main implantdelivery catheter further comprises a main implant delivery cathetersheath which may be openable or removable at said internal end and amain implant delivery catheter lumen containing within a compressed orfolded endovascular implant. Further in such an exemplary embodiment, anendovascular implant comprises a non-elastic tubular implant body withan elastic proximal end terminating in a proximal sealablecircumferential collar controlled by a proximal variable sealing devicewhich is operated by a proximal control lead that traverses said mainimplant delivery catheter and exits at said external end for interfaceby an operator, such that said proximal sealable circumferential collarmay be expanded or contracted by said operator to achieve a fluid-tightseal between said proximal sealable circumferential collar and theinternal walls of said blood vessel proximal to said vascular defect.Moreover, in such an exemplary embodiment, an endovascular implantfurther comprises a non-elastic tubular implant body with an elasticdistal end terminating in a distal sealable circumferential collarcontrolled by a distal variable sealing device which is operated by adistal control lead that exits said main implant delivery catheter atsaid external end for interface by an operator, such that said distalsealable circumferential collar may be expanded or contracted by saidoperator to achieve a fluid-tight seal between said distal sealablecircumferential collar and the internal walls of said blood vesseldistal to the vascular defect.

In an alternate exemplary embodiment of the present disclosure, anendovascular implant comprises a non-elastic tubular implant body withan elastic proximal end terminating in a proximal sealablecircumferential collar controlled by a proximal variable sealing devicewhich is operated by a proximal control lead that traverses said mainimplant delivery catheter and exits at said external end for interfaceby an operator, such that said proximal sealable circumferential collarmay be expanded or contracted by said operator to achieve a fluid-tightseal between said proximal sealable circumferential collar and theinternal walls of said blood vessel proximal to said vascular defect.Moreover, in such an exemplary embodiment, an endovascular implantfurther comprises a non-elastic tubular implant body with an elasticdistal end with a distal elastic circumferential collar of an expandablemesh or lattice formation that may be expanded by intralumenal balloondilatation by said operator to achieve a fluid-tight seal between saiddistal elastic circumferential collar and the internal walls of saidblood vessel distal to the vascular defect. In such an embodiment,particularly in the iliac arteries, the distal aspect of the endograftrequires less pressure for an effective seal, and more length ofarterial wall is usually available to allow an expandable mesh collar tobe employed, compared with the proximal seal which often may be requiredto accommodate a shortened and/or angulated aortic neck.

In yet another embodiment of the present disclosure, the distal seal,particularly in the iliac arteries, may be effected using aself-expanding mesh endoskeleton or exoskeleton collar attached to theelastic distal end, provided such that the self-expanding meshendoskeleton or exoskeleton collar is designed such that longitudinaltraction on the deployed mesh causes the mesh to elongate and reduce itscircumference. This would allow instrumentation to be inserted such as ahook that could adjust the distal seal location post implant deployment.Again, in such an embodiment, particularly in the iliac arteries, thedistal aspect of the endograft requires less pressure for an effectiveseal, and more length of arterial wall is usually available to allow aself-expanding mesh endoskeleton or exoskeleton collar to be employed,compared with the proximal seal which often must accommodate a shortenedand/or angulated aortic neck.

Exemplary endografts of the present disclosure comprising self-expandingmesh endoskeleton or exoskeleton collar may further comprise retentiontines of any shape with or without barbs for better retention againstthe receiving vessel walls. Moreover, the retention tines in suchendografts of the present disclosure may be provided as separatecomponents that are affixed to the self-expanding mesh endoskeleton orexoskeleton collars, or they may be fabricated as integral componentsthereof.

In a further exemplary embodiment according to the present disclosure,an implant interface is provided for a sealable attachment of an implantto a wall within the lumen of a blood vessel or other anatomic conduit.

In a yet further exemplary embodiment according to the presentdisclosure, an implant interface is provided for a sealable attachmentof an implant to a wall within the lumen of a blood vessel or otheranatomic conduit, wherein the sealable attachment provides forauto-adjustment of the seal while maintaining wall attachment toaccommodate post-implantation wall remodeling.

In a still further exemplary embodiment according to the presentdisclosure, an implant interface is provided for a sealable attachmentof an implant to a wall within the lumen of a blood vessel or otheranatomic conduit, wherein the sealable attachment provides for are-docking mechanism to allow post-implantation correction of sealdefects.

Yet other exemplary embodiments of endografts and endograft deliverysystems according to the present disclosure have steering mechanismsthat allow an operator to remotely angulate the implant as desired fordifficult anatomic site requirements. Still other exemplary embodimentsof endografts and endograft delivery systems according to the presentdisclosure serve as universal endograft cuffs, being first placed tooffer their advantageous anatomic accommodation capabilities, and thenserving as a recipient vessel for other endografts, includingconventional endografts.

Further exemplary embodiments of endografts according to the presentdisclosure provide for endovascular treatment of complex anatomicvascular pathologies involving the aortic arch including aneurysms anddissecting aneurysms of the aortic arch.

Referring now in more detail to the drawings, in which like numeralsindicate like elements throughout the several views, FIG. 1A shows aproximal circumferential sealable implant interface 100 according to thepresent disclosure, comprising a sealer belt 60, sealer belt channelside walls 5 provided in an overlapping loop and with a sealer beltchannel 35 therewithin, a plurality of retention tines 30 and acompressive foam gasket 90 within said sealer belt channel 35, and asealing device housing 15, all contained within an elastic sealablecollar 10 which is shown in the embodiment of FIG. 1A joined to andcontinuous with a tubular graft main body 25.

FIG. 1A further shows the proximal circumferential sealable implantinterface 100 in place within the lumen defined by an aortic wall 40,and with an injection dye catheter 22 traversing the sealable implantinterface 100 and adjoining tubular graft main body 25. Imbeddedretention tines 30 are shown within the aortic wall 40. Also shown inFIG. 1A is a control lead 20 extending distally from its attachment tothe sealing device housing 15 to exit through an arteriotomy site foroperative control by an operator (not shown in FIG. 1A).

In alternate embodiments of the present disclosure not shown in FIGS.1A-11 herein, a circumferential sealable implant may comprise afreestanding implant which is coupled with or otherwise affixed to atubular graft at the time of implantation.

FIG. 1B shows a detailed view of one embodiment of a sealable implantinterface according to the present disclosure. In FIG. 1B, the sealableimplant interface 100 comprises a sealer belt 60 and sealer belt channelside walls 5 provided in an overlapping loop and with a sealer beltchannel 35 therewithin to contain a plurality of retention tines 30 anda compressive foam gasket [not shown in FIG. 1B], and a sealing devicehousing 15. Within said sealing device housing 15, a sealer gear 50 isrotatably mounted to interface with sealer gear retainment slots [notshown in FIG. 1B] located on the sealer belt 60, such that rotation ofthe sealer gear 50 by operator action on an attached control lead 20 maycause movement of said sealer belt 60 with respect to said sealer gear50.

In the embodiment shown in FIG. 1B, the sealer gear 50 is furtherprovided with a spring interface 55 with said control lead 20, such thatan operator first depresses the spring interface 55 with said controllead 20 to allow rotation of the sealer gear 50 and resultant movementof the sealer belt 60. When the spring interface 55 is not depressed,rotation of the sealer gear 50 is blocked by action of a locking member(not shown in FIG. 1B).

FIG. 2 provides a more detailed view of an embodiment of the coil springdrive gear design of the sealer gear mechanism described in FIG. 1B.FIG. 2 shows a sealer belt 60, sealer belt channel side walls 5 providedin an overlapping loop and with a sealing device housing 15 and a sealerbelt channel 35 with a plurality of uniformly distributed sealer gearretainment slots 62 therewithin configured to receive the teeth of asealer gear 50. The sealer belt channel 35 is provided to contain aplurality of retention tines 30 and a compressive foam gasket [not shownin FIG. 2].

The sealer belt 60 as shown in FIG. 2 and in all other embodiments ofthe present disclosure may be fabricated of any suitably strongbiocompatible material, including, but not limited to titanium,stainless steel, cobalt chromium alloys, other metals, other metalalloys, plastics, or ceramics.

FIG. 2 further illustrates an embodiment in which the retention tines 30are pivotably mounted within said sealer belt channel 35 to permit theirfolding within said channel 35 within the overlapping segments of thesealer belt 60.

The coil spring drive gear design of the sealer gear 55 is also detailedin FIG. 2. Pressure transmitted by an operator through a control lead 20to the central axel 21 of the sealer gear 50 first depresses the springinterface 55 within said sealer gear, allowing the sealer gear to rotateupon subsequent receipt of rotational forces applied by said user tosaid control lead 20.

FIG. 3 shows a perspective view of an embodiment of an implant interfacewith an uncompressed spring interposition mechanism according to thepresent disclosure. The exemplary sealable implant interface 100 asshown in FIG. 3 resembles the embodiment of FIG. 1B, with a sealer belt60, sealer belt channel side walls 5 provided in an overlapping loop andwith a sealer belt channel 35 therewithin to contain a plurality ofretention tines 30 and a compressive foam gasket [not shown in FIG. 1B],and a sealing device housing 15. Within said sealing device housing 15,a sealer gear 50 is rotatably mounted to interface with sealer gearretainment slots [not shown in FIG. 3] located on the sealer belt 60,such that rotation of the sealer gear 50 by operator action on anattached control lead 20 may cause movement of said sealer belt 60 withrespect to said sealer gear 50.

In the embodiment of FIG. 3, however, a segment of sealer belt 60 isreplaced by an interposed and attached coiled spring 65 shown in adecompressed state. In use, motion imparted to the sealer gear 50 of thesealable implant interface 100 of FIG. 3 may serve to compress ordecompress the spring 65.

FIG. 4 shows the same embodiment of an implant interface as FIG. 3, butwith a compressed spring-tine mechanism. Compression of the spring 65creates and maintains radial tension that allows such an embodiment ofthe present disclosure to automatically provide a fixed amount ofadjustment in the event of post-implantation remodeling and dilation ofthe aorta or recipient blood vessel or anatomic conduit.

FIG. 5 provides a detailed view of an alternate embodiment of an implantinterface with an electromagnetic re-docking mechanism and spring-loadedremodeling attachment members according to the present disclosure. InFIG. 5 a detail of an implant interface comprises sealer belt 60 withside walls 5 provided in an overlapping loop and with a sealer beltchannel 35 therewithin to contain a plurality of retention tines 30, aplurality of uniformly distributed sealer gear retainment slots 62therewithin configured to receive the teeth of a sealer gear 50, and acompressive foam gasket [not shown in FIG. 5], and a sealing devicehousing 15 containing a sealer gear 50.

Also in FIG. 5, a coil spring drive gear design of the sealer gear 55 isalso detailed. Pressure transmitted by an operator through a controllead 20 attached to the central axel 21 of the sealer gear 50 firstdepresses a spring interface 55 within said sealer gear, allowing thesealer gear to rotate upon subsequent receipt of rotational forcesapplied by said user to said control lead 20.

Furthermore, FIG. 5 shows one of more retention tines 30 pivotablyattached to the side walls 63 of the sealer belt 60, such thatadvancement or retraction of the sealer belt 60 by rotational action ofthe sealer gear causes said tines to either extend outwardly from saidsealer belt 60 or retract within the sealer belt channel 35 when thecircumference of the sealer belt 60 is made smaller. In the embodimentshown in FIG. 5, one or more of the retention tines 30 may be furtherprovided with a tine limiter element 70 which serves to limit the depthto which the retention tine 30 may be extended into the wall of therecipient blood vessel or other anatomic conduit.

In addition, as shown in FIG. 5, one or more of the retention tines 30may be attached to the sealer belt 60 with a pre-tensioned tine mountingelement 75 (also called pre-tensioned spring element 75, throughout)that serves to exert an outward radial force on its related retentiontine 30 upon deployment.

FIGS. 6A-6D provides detailed views of several exemplary embodiments ofspring-loaded remodeling attachment members according to the presentdisclosure.

FIG. 6A shows a sealer belt 60 with a retention tine 30 mounted at anerect angle thereto, said retention tine 30 further comprising a tinelimiter element 70 which serves to limit the depth to which theretention tine 30 may be extended into the wall of the recipient bloodvessel or other anatomic conduit.

In FIGS. 6A and 6B, said retention tine 30 may be welded or otherwiseaffixed to a pre-tensioned tine mounting element 75 that serves to exertan outward radial force on its related retention tine 30 upondeployment. As shown in FIGS. 6A and 6B, the pre-tensioned tine mountingelement 75 has two ends 80 and 85. In the embodiment of the presentdisclosure as shown in FIGS. 6A and 6B, end 80 is welded or permanentlyaffixed to the surface of the sealer band 60 (also called sealer belt60) and end 85 is free to slide across the surface of the sealer band 60when longitudinal force is applied to the associated retention tine 30.

In FIGS. 6C and 6D, said retention tine 30 may be welded or otherwiseaffixed to a pre-tensioned tine mounting element 75 that serves to exertan outward radial force on its related retention tine 30 upondeployment. As shown in FIGS. 6C and 6D, the pre-tensioned tine mountingelement 75 has two ends 80 and 85. In the embodiment of the presentdisclosure as shown in FIGS. 6C and 6D, both ends 80 and 85 are weldedor permanently affixed to the surface of the sealer band 60.

The pre-tensioned tine mounting elements 75 as shown in FIGS. 6A-6Dmaintain radial tension that allows such an embodiment of the presentdisclosure to automatically provide a fixed amount of adjustment in theevent of post-implantation remodeling and dilation of the aorta orrecipient blood vessel or anatomic conduit.

FIGS. 7A-7C show the relationship among the retention tines 30,pre-tensioned spring elements 75, compressible foam gasket 90, andaortic wall 40 in an exemplary embodiment according to the presentdisclosure.

FIG. 7A is a detailed cross sectional view of an exemplary embodiment ofspring-loaded remodeling attachment member contained within anuncompressed foam gasket according to the present disclosure. In FIG.7A, a retention tine 30 with a tine limiter element 70 is shown attachedto a sealer band 60 by a pre-tensioned spring element 75. As shown inFIG. 7A, the retention tine is completely covered by the foam gasket 90in an uncompressed or pre-deployment condition.

Upon deployment, as shown in FIG. 7B, the foam gasket 90 is compressedbetween the sealer band 60 and the aortic wall 40, with penetration ofthe retention tine 30 into the aortic wall 40. The extent of penetrationof the retention tine 30 into the aortic wall 40 is limited by a tinelimiter element 70 as shown In FIGS. 7B and 7C. FIG. 7B shows thepre-tensioned spring element 75 at maximal tension.

FIG. 7C is a detailed cross sectional view of the same exemplaryembodiment as shown in FIG. 7B, with deployment of retention tines 30into an aortic wall 40 through a compressed foam gasket 90 with fullextension of the pre-tensioned spring element 75 to accommodate aorticremodeling according to the present disclosure.

The embodiments of the retention tines as shown in the present drawingsshow the retention tines to be substantially straight, and at aboutninety degree angles relative to the sealer band 60. However, otherembodiments on the present disclosure may comprise curved or otherwiseangled retention tines, or retention tines that may be constructed ofNitinol or other shape/memory materials so that such retention tinesbecome angled or curved upon deployment to further strengthen theattachment of said retention tines to the aortic walls or otherrecipient anatomic tissues. The retention tines in various embodimentsof endografts of the present disclosure may be of any cross-sectionalshape, and may further be terminally rounded, sharpened, tapered, orhooked,

In still further embodiments of the retention tines in endografts of thepresent disclosure, the retention tines may be barbed or non-barbed.Furthermore, the number of retention tines associated with a sealer bandin various embodiments of the present disclosure may vary. Preferredembodiments of sealer bands or sealable circumferential collars of thisdisclosure comprise at least two retention tines. Moreover, theretention tines in endografts of the present disclosure may be providedas separate components that are affixed to the sealer bands or sealablecircumferential collars, or they may be fabricated as integralcomponents thereof.

FIGS. 8A-8D provide detailed views of several alternate exemplaryembodiments of spring-loaded remodeling attachment members according tothis disclosure.

FIG. 8A shows a cross section of an embodiment of a sealer belt withattached retention tines according to the present disclosure. In FIG.8A, a retention tine 30 with a tine limiter element 70 is affixed to asupport element 105 which in turn is affixed to sealer belt channel sidewalls 5 which are connected to a sealer belt 60. Elements may be affixedin this and other embodiments of the present disclosure by any means,including but not limited to welding, cementing, or mechanical fixation.A support element 105 in various embodiments of the present disclosuremay further be inserted into and retained in bores or detents in thesealer belt channel side walls 5 (not shown in FIG. 8A). Alternatelystill, in some embodiments of the present disclosure, a retention tine30 may be cast or otherwise fabricated as a single unit with a supportelement 105.

In various embodiments of the present disclosure, a sealer belt 60 andsealer belt channel side walls 5 may form a channel of angles rangingfrom about 10.degree. to about 170.degree.; more preferably from about40.degree. to about 140.degree.; and most preferably about 90.degree. Inother embodiments of the present disclosure, a sealer belt 60 and sealerbelt channel side walls 5 may form a continuous structure which may becircular, ovoid, semi-circular, or semi-ovoid on cross section.

Also, in various embodiments of this disclosure, the support element 105may be a rigid structure or it may be a pre-tensioned spring. Similarly,in various embodiments of the present disclosure, the retention tine 30may be straight (as shown in FIG. 8A) or it may be curved or helical insome or all its length. A retention tine 30 of the present disclosuremay be fabricated from a shape memory material such as Nitinol or othermetals, metal alloys, ceramics, plastics, or combinations thereof withshape memory characteristics to allow such a retention tine 30 torestore and maintain a desired shape upon its deployment.

FIG. 8B shows a side view of the sealer belt with attached retentiontines of FIG. 8A. In FIG. 8B, a retention bore 110 is shown in a sealerbelt channel side wall 5 where it receives and retains the supportelement 105 and supports the retention tine 30 with a tine limiterelement 70. Also in FIG. 8B, the sealer belt 60 is shown to comprise aplurality of uniformly distributed sealer gear retainment slots 62therewithin configured to receive the teeth of a sealer gear [not shownin FIG. 8B].

FIG. 8C shows a top view of FIG. 8A, with a retention tine 30 with atine limiter element 70 affixed to a support element 105 which in turnis affixed to sealer belt channel side walls 5 which are connected to asealer belt 60 with a plurality of uniformly distributed sealer gearretainment slots 62.

FIG. 8D similarly shows a top view of the sealer belt with attachedretention tines of FIG. 8B, with a retention bore 110 shown in a sealerbelt channel side wall 5 where it receives and retains the supportelement 105 and supports the retention tine 30 with a tine limiterelement 70. Also in FIG. 8D, the sealer belt 60 is shown to comprise aplurality of uniformly distributed sealer gear retainment slots 62therewithin configured to receive the teeth of a sealer gear [not shownin FIG. 8D].

FIGS. 9A and 9B are detailed views of another exemplary embodiment ofspring-loaded remodeling attachment members according to the presentdisclosure, in which the band containing attachment members is mountedto a spring-tensioned suspension. FIG. 9A is a lateral view of the sameexemplary embodiment of spring-loaded remodeling attachment shown incross section in FIG. 9B.

In FIGS. 9A and 9B, one or more retention tines 30 with tine limiterelements 70 are affixed to support elements 105 which in turn areaffixed to sealer belt channel side walls 5 which are connected to asealer belt 60. A retention bore 110 shown in a sealer belt channel sidewall 5 where it receives and retains the support element 105 andsupports the retention tine 30 with a tine limiter element 70.

In the exemplary embodiment shown in FIGS. 9A and 9B, Retentionfasteners 125 affixed to the sealer belt channel side walls 5 arereceived and retained in slots in channel expansion elements 130. Thechannel expansion elements 130 are permanently affixed to a sealer beltexpansion base 66, which may further be provided with a plurality ofuniformly distributed sealer gear retainment slots 62 therewithinconfigured to receive the teeth of a sealer gear [not shown in FIG. 9Aor B]. Separating the sealer belt 60 and sealer belt expansion base 66are one or more expansion spring elements 120 which exert aspring-loaded tension between the sealer belt 60 and sealer beltexpansion base 66. In FIGS. 9A and 9B, the one or more expansion springelements 120 are shown in a compressed or non extended state, with closeapproximation between the sealer belt 60 and sealer belt expansion base66.

Retention fasteners 125 as used in the present disclosure may be screws,rivets, pins, or other fasteners, and may be affixed to the sealer beltchannel side walls 5 by welding, adhesives, screw threads rivets, orother known means of attaching.

FIGS. 10A and 10B are detailed views of the same exemplary embodiment ofspring-loaded remodeling attachment members according to the presentdisclosure as shown in FIGS. 9A and 9B, but showing the one or moreexpansion spring elements 120 in a decompressed or fully extended state,with near maximum separation between the sealer belt 60 and sealer beltexpansion base 66. Separation between the sealer belt 60 and sealer beltexpansion base 66 is limited by the amount of distance allowed by thesliding action of the retention fasteners 125 within the slots of thechannel expansion elements 130.

In the exemplary embodiment of spring-loaded remodeling attachmentmembers according to the present disclosure as shown in FIGS. 9A, 9B,10A, and 10B, any enlargement in the diameter of the recipient anatomicconduit or blood vessel such as post-implantation aortic remodelingwould allow the embodiment as shown to automatically accommodate theenlargement and maintain a leak proof seal using the spring tensionedsuspension to the limit of the expansion capacity of that suspension.

FIG. 11 is a perspective view of an embodiment of an implant interfacewith a circumferential sealable collars and a variable sealing devicewith a re-docking mechanism according to the present disclosure, withthe re-docking mechanism not connected to a removable re-docking controllead.

A re-docking mechanism is desirable, should post-implantation changes inthe position or size of the implant be desired to either preventleakages or provide a more advantageous anatomic position.

In FIG. 11, an exemplary endovascular implant graft 200 of thisdisclosure is shown in an anatomic position within aortic walls 218 andtraversing an aneurysm sac 215, said graft comprising a proximal end 205and a distal end 210. An injection catheter 220 is shown extendingthrough the proximal end 205 of the exemplary endovascular implant graft200. A tubular corrugated fabric graft 250 is joined proximally by aproximal elastic sealable collar 252. Within the proximal elasticsealable collar 252 are contained a sealer belt 230 provided in anoverlapping loop and with a sealer belt channel 225 therewithin, aplurality of retention tines 227 and a compressive foam gasket 240within the sealer belt channel 225, and a sealing device housing 235.Extending distally within the lumen of the tubular corrugated fabricgraft 250 is a re-dockable implant control lead 245.

FIG. 12 is a perspective view of an embodiment of the same exemplaryendovascular implant graft 200 of the present disclosure as shown inFIG. 11, but with a removable re-docking control lead 255 engaged withthe re-dockable implant control lead 245. The re-docking control lead255 as shown in FIG. 12 has been placed into the blood vessel through adistal arteriotomy site (not shown in FIG. 12) by an operator whoretains external operative control to allow re-docking and the desiredalteration in the configuration and deployment of the endovascularimplant graft 200.

Re-docking of the re-dockable implant control lead 245 with a removablere-docking control lead 255 may be achieved by one of several mechanismsaccording to the present disclosure. The re-dockable implant controllead 245 may be provided with a helix, loop, or distal hook [not shownin the figures herein] that may be snared or otherwise engaged by aguide wire or by the removable re-docking control lead 255. Alternately,magnetic and/or electromagnetic attraction may be employed between there-dockable implant control lead 245 and the removable re-dockingcontrol lead 255 to allow their engagement in a high flow vascularenvironment. Alternately still, imaging technologies such asintravascular ultrasound and/or optical coherence tomography may beemployed to allow an operator using basic endovascular invasivetechniques to re-dock and interface with the re-dockable implant controllead 245 post-implantation.

FIGS. 13-15 show perspective anatomic views of an embodiment of anendograft implant according to the present disclosure in which theimplant delivery mechanism is remotely steerable to allow a variableplane of delivery for implantation. The anatomic conditions in the aortaproximal to the desired recipient site for endograft implantation may beirregular or tortuous, ideally requiring an angled deployment of anendograft's proximal interface. Conventional endograft devices do notpermit such angled deliveries.

In FIG. 13, an exemplary abdominal aortic aneurysm 300 is shown with anarrow and angled proximal aortic neck 305. A delivery catheter 310 isshown arising from the right iliac artery 312. Extending partially fromthe delivery catheter 310 is the proximal portion of an exemplaryendograft 315 of the present disclosure. As shown in FIG. 13, theendograft 315 comprises a proximal sealable circumferential collar 318which is connected to a first control wire lead 330 with a removablefirst control attachment 325 and a second control wire lead 335 with aremovable second control attachment 320. Multiple types of attachmentsare used in various embodiments of the present disclosure to attach thefirst control wire leads 330 and second control wire leads 335 to theendograft 315. In a preferred embodiment, a removable first controlattachment 325 and a removable second control attachment 320 areprovided with a coiled tip that may be attached by screw action into theproximal sealable circumferential collar 318. In one aspect and asillustrated in FIGS. 13 and 14, the first control wire lead 330 and thesecond control wire lead 335 can be of such strength that one controlwire lead can be pulled by the operator and the other control wire leadcan be pushed by the operator, to achieve the desired angle toaccommodate a proper seal.

FIG. 14 shows the endograft implant of FIG. 13 in which the endograft315 has been steered to a desired angular plane of delivery. Thus, thecontrol wire leads have been used to achieve and maintain a properproximal seal angle, which is maintained while the gasket is enlargedand the seal is achieved by deploying the times.

FIG. 15 shows the endograft implant of FIG. 14 in which the proximalsealable circumferential collar 318 has been delivered to the desiredangular site in the proximal aorta 305 and a seal has been accomplishedaccording to the present disclosure by mechanical alteration of theproximal sealable circumferential collar 318 to seal against and thenattach to the aortic wall 305. In FIG. 15, the tines have been deployed,and the removable first control attachment 325 and the removable secondcontrol attachment 320 are shown disengaged from the proximal sealablecircumferential collar 318. Also in FIG. 15, the first control wire lead330, the removable first control attachment 325, the second control wirelead 335, and the removable second control attachment 320 are shownbeing removed through the delivery catheter 310.

FIG. 16 shows a perspective anatomic view of an exemplary embodiment ofan endograft implant according to this disclosure in which the implantis a universal proximal cuff endovascular implant for treatment of anabdominal aortic aneurysm. Endografts with the features shown in thevarious embodiments of the present disclosure have unique abilities toaccommodate to anatomic variations that would preclude or compromise useof conventional endograft systems. For example, non-conducive anatomycan arise by virtue of angulation, calcific disease, thrombus, or ashort neck. The universal proximal cuff implants of the presentdisclosure allow an operator to make use of their ability to securelyseal and attach in anatomic sites where conventional endografts cannotbe securely placed, and then allow a conventional endograft to securelydock with the universal proximal cuff endovascular implants distally.

In FIG. 16, a universal proximal cuff endovascular implant 400 has beenplaced in a narrow and angulated proximal aortic neck 410 and extendsinto an abdominal aortic aneurysm 405. The universal proximal cuffendovascular implant 400 comprises a proximal sealable circumferentialcollar 415 of the present disclosure, which is connected to an elasticproximal end 420 of a non-elastic tubular implant body 425 with a distaldocking opening 430. The device of FIG. 16 has been delivered andimplanted with the techniques of this disclosure, and contains avariable sealing device and attachment retention tines of thisdisclosure (not shown in FIG. 16). Once the device of FIG. 16 has beenimplanted as shown, an operator may engage and deliver any endograftincluding conventional endografts to the distal docking opening 430.Thus, the universal proximal cuff endovascular implant 400 provides aconduit that is suspended into, or extends into, the into an abdominalaortic aneurysm 405, that can serve as a neck conducive for docking anyknown endograft.

FIG. 17 shows a perspective anatomic view of an exemplary embodiment ofan endograft implant according to the present disclosure in which theimplant is a universal proximal cuff endovascular implant for treatmentof a thoracic aortic aneurysm.

In FIG. 17, a universal proximal cuff endovascular implant 500 has beenplaced in a narrow and angulated proximal aortic neck 510 and extendsinto a descending thoracic aortic aneurysm 505. The universal proximalcuff endovascular implant 500 comprises a proximal sealablecircumferential collar 515 of the present disclosure, which is connectedto an elastic proximal end 520 of a non-elastic tubular implant body 525with a distal docking opening 530. The device of FIG. 17 has beendelivered and implanted with the techniques of the present disclosure,and contains a variable sealing device and attachment retention tines ofthe present disclosure (not shown in FIG. 16). Once the device of FIG.17 has been implanted as shown, an operator may engage and deliver anyendograft including conventional endografts to the distal dockingopening 530. FIG. 17 shows such a delivery in progress, with a guidewire 535 in place, and a delivery catheter 540 containing an endograftbeing introduced for delivery into the distal docking opening 530.

FIGS. 18-20 show an exemplary pathologic condition with a complex aorticarch with a first aneurysm involving the aortic arch and a secondaneurysm involving the descending aorta. Such a condition would not betreatable with conventional endografts. In FIG. 18, the ascending aorta605 arises above the aortic valve 615 and gives off the coronaryarteries 610. The area between the ascending aorta 605 and thedescending thoracic aorta 645 is the aortic arch 600. The aortic arch600 gives rise to the innominate artery 620 which divides into the rightsubclavian artery 628 and right common carotid artery 625, The aorticarch 600 further gives rise to the left common carotid artery 630 andthe left subclavian artery 635. The right subclavian artery 628, rightcommon carotid artery 625, left common carotid artery 630 and the leftsubclavian artery 635 are critical blood vessels to supply arterialblood to the arms, head, neck, and brain. FIG. 18 further shows a largefirst aneurysm 640 involving the aortic arch 600 and a second aneurysm650 involving the descending thoracic aorta 645.

FIG. 19 shows the anatomic situation of FIG. 18, in which extra-anatomicsurgical bypass has been performed with a first bypass 655 between theright common carotid artery 625 and left common carotid artery 630 and asecond bypass 660 between the left common carotid artery 630 and theleft subclavian artery 635.

FIG. 20 shows the same view as FIG. 19, with exemplary endovascularplacement of three embodiments of endografts of the present disclosureto traverse the pathology and maintain vital circulation.

In FIG. 20, a first endograft 670 of the present disclosure has beenplaced through the aortic arch 600 with an attachment in the ascendingaorta just distal to the coronary arteries using a first proximalsealable circumferential collar 672 of the present disclosure. The firstendograft 670 as shown has an innominate branch 620 with an innominatesealable circumferential collar 622. The first endograft 670 traversesand excludes the first aneurysm 640 and terminates in a distal cuff 675at the distal end of the aortic arch 600. A second endograft 680connects to the distal cuff 675 of the first endograft 670 using asecond proximal sealable circumferential collar 676 of the presentdisclosure's design. As shown in FIG. 20, the second endograft 680traverses a segment of the descending aorta 645. The second endograft680 may be fenestrated [not shown in FIG. 20] either in manufacture orsurgically to allow collateral circulation to be maintained to thespinal and other vessels arising from that segment of the descendingaorta 645.

FIG. 20 further shows a second aneurysm 650 in the descending aorta 645.In FIG. 20, this is traversed and excluded by a third endograft 690 ofthe present disclosure, which is shown sealably attaching to the secondendograft distal cuff 684 with a third proximal sealable circumferentialcollar 688 of the present disclosure's design. The third endograft 690is shown attaching distally with a distal sealable circumferentialcollar 696 of the present disclosure's design.

Thus, in FIG. 20, circulation is maintained to the arms, head, brain,and spine, while excluding two difficult thoracic aneurysms. Thisexemplary combination of endografts of the present disclosure and arelatively minor vascular procedure allows complete treatment of verydifficult anatomic pathology that would be beyond the reach ofconventional endovascular techniques and devices. This makes a varietyof aortic arch pathologies within the scope of the devices and methodsof this disclosure, including aortic arch aneurysms, dissectinganeurysms of the aortic arch, transposition of the great vessels, andother complex pathologies.

In addition to the making and use of endovascular implant grafts, otheranatomic applications are also within the scope of the presentdisclosure. As an example, the mechanisms and principles disclosedherein may be applied to gastrointestinal disorders, where anintralumenal bypass may be desirable that may be placed using endoscopictechniques.

Crohn's disease (also known as regional) is a chronic, episodic,inflammatory bowel disease (IBD) and is generally classified as anautoimmune disease. Crohn's disease can affect any part of thegastrointestinal tract from mouth to anus; as a result, the symptoms ofCrohn's disease vary among afflicted individuals. The disease ischaracterized by areas of inflammation with areas of normal liningbetween in a symptom known as skip lesions. The main gastrointestinalsymptoms are abdominal pain, diarrhea (which may be bloody, though thismay not be visible to the naked eye), constipation, vomiting, weightloss or weight gain. Crohn's disease typically involves the terminalileum.

In an exemplary embodiment of a gastrointestinal aspect of the presentdisclosure, a tubular graft comprising proximal and distal sealableimplant interfaces as disclosed herein is endoscopically placed andaffixed proximally to and distally to a segment of intestine affected byCrohn's disease to divert the intestinal contents therethrough.

By providing an intraintestinal bypass for the conduit of intestinalcontents though areas affected by Crohn's disease, local inflammatoryresponse and sequelae in the affected areas are reduced.

Although the foregoing embodiments of the present disclosure have beendescribed in some detail by way of illustration and example for purposesof clarity and understanding, it will be apparent to those skilled inthe art that certain changes and modifications may be practiced withinthe spirit and scope of the present disclosure. Therefore, thedescription and examples presented herein should not be construed tolimit the scope of the present disclosure.

Co-pending U.S. patent application Ser. No. 11/888,009, filed Jul. 31,2007, is incorporated by reference herein in its entirety. Any otherpublications and patents mentioned in this disclosure are incorporatedherein by reference in their entireties, for the purpose of describingand disclosing the constructs and methodologies described in thosepublications and patents, which might be used in connection with themethods of this disclosure. Any publications and patents discussed aboveand throughout the text are provided solely for their disclosure priorto the filing date of the present application. Nothing herein is to beconstrued as an admission that the inventors are not entitled toantedate such disclosure by virtue of prior invention.

In any application before the United States Patent and Trademark Office,the Abstract of this application is provided for the purpose ofsatisfying the requirements of 37 C.F.R. § 1.72 and the purpose statedin 37 C.F.R. § 1.72(b) “to enable the United States Patent and TrademarkOffice and the public generally to determine quickly from a cursoryinspection the nature and gist of the technical disclosure.” Therefore,the Abstract of this application is not intended to be used to construethe scope of the claims or to limit the scope of the subject matter thatis disclosed herein. Moreover, any headings that may be employed hereinare also not intended to be used to construe the scope of the claims orto limit the scope of the subject matter that is disclosed herein. Anyuse of the past tense to describe an example otherwise indicated asconstructive or prophetic is not intended to reflect that theconstructive or prophetic example has actually been carried out.

We claim:
 1. A vascular system comprising: a delivery apparatusincluding a catheter and a control lead, wherein the catheter includes alumen extending therethrough, and wherein the control lead extendsthrough the lumen of the catheter and is configured to be manipulated bya user of the vascular system; and an endovascular device releasablycoupled to the delivery apparatus and including an implant body, a sealextending radially outwardly from the implant body, and one or moretissue engaging elements, each having a free end and fixed end, whereinthe implant body has an inflow end portion, an outflow end portion, anda central longitudinal axis extending from the inflow end portion to theoutflow end portion, wherein the seal is configured to contact nativevascular tissue to reduce leakage between the native vascular tissue andthe implant body, wherein the tissue engaging elements are pivotablerelative to the seal from a compressed state to an expanded state,wherein in the compressed state, the free ends of the tissue engagingelements are positioned so as to disengage the native vascular tissue,and wherein in the expanded state, the free ends of the tissue engagingelements extend outwardly from the seal and are configured to engage thenative vascular tissue.
 2. The vascular system of claim 1, wherein theendovascular device further comprises a housing coupled to the implantbody and a rotatable member disposed in the housing, wherein therotatable member can be releasably coupled to the control lead of thedelivery apparatus, wherein rotating the control lead such that therotatable member rotates in a first direction results in radialexpansion of the implant body, and wherein rotating the control leadsuch that the rotatable member rotates in a second direction results inradial compression of the implant body.
 3. The vascular system of claim2, wherein rotating the control lead such that the rotatable memberrotates in the first direction results in one or more of the tissueengaging elements moving from the compressed state to the expandedstate.
 4. The vascular system of claim 2, wherein rotating the controllead such that the rotatable member rotates in the second directionresults in one or more of the tissue engaging elements moving from theexpanded state to the compressed state.
 5. The vascular system of claim2, wherein the rotatable member is configured to rotate relative to thehousing and the implant body about an axis that is radially offsetrelative to the central longitudinal axis of the implant body.
 6. Thevascular system of claim 2, wherein the endovascular device furthercomprises a gear coupled to the implant body, and wherein the rotatablemember is a locking member configured to selectively couple the controllead to the gear.
 7. The vascular system of claim 6, wherein the lockingmember is movable between an engaged position and a disengaged position,wherein in the engaged position, the locking member contacts the gear,and the locking member and the gear rotate together when the controllead is rotated by the user, wherein in the disengaged position, thelocking member is spaced from the gear and the locking member rotateswithout rotating the gear when the control lead is rotated by the user.8. The vascular system of claim 2, wherein the control lead comprises ashaft configured to selectively engage the rotatable member.
 9. Thevascular system of claim 8, wherein the rotatable member comprises anattachment portion configured to receive the shaft of the control lead.10. The vascular system of claim 1, wherein the implant body comprisesmetal and the seal comprises PTFE.
 11. A vascular system comprising: adelivery apparatus including a catheter and a plurality of controlleads, wherein the catheter includes a lumen extending therethrough, andwherein the control leads extend through the lumen of the catheter andare configured to be manipulated by a user of the vascular system; andan endovascular device releasably coupled to the delivery apparatus andincluding an implant body, a plurality rotatable members mounted to theimplant body, and a plurality of tissue engaging elements, wherein eachof the rotatable members is releasably coupled to a respective controllead of the delivery apparatus and is configured to rotate relative tothe implant body, wherein the tissue engaging elements are pivotablerelative to the implant body from a compressed state to an expandedstate, wherein in the compressed state, the tissue engaging elements arepositioned so as to disengage native vascular tissue, and wherein in theexpanded state, the tissue engaging elements extend outwardly from theimplant body and are configured to engage the native vascular tissue.12. The vascular system of claim 11, wherein rotating the control leadssuch that the rotatable members rotate in a first direction results inradial expansion of the implant body, and wherein rotating the controlleads such that the rotatable members rotate in a second directionresults in radial compression of the implant body.
 13. The vascularsystem of claim 11, wherein the control leads can be rotatedsimultaneously by the user such that the rotatable members rotatesimultaneously.
 14. The vascular system of claim 11, wherein each of thecontrol leads is coupled to an outflow end portion of the implant body.15. The vascular system of claim 11, wherein each of the control leadsis coupled to an inflow end portion of the implant body.
 16. Thevascular system of claim 11, wherein the implant body has an inflow endportion, an outflow end portion, and a central longitudinal axisextending from the inflow end portion to the outflow end portion,wherein the control leads are configured to rotate about respective axesthat are radially offset relative to the central longitudinal axis ofthe implant body, and wherein each of the rotatable members iscircumferentially offset relative to the other rotatable members.
 17. Avascular system comprising: a delivery apparatus including a catheterand a control lead, wherein the catheter includes a lumen extendingtherethrough, and wherein the control lead extends through the lumen ofthe catheter and is configured to be manipulated by a user of thevascular system; and an endovascular device releasably coupled to thedelivery apparatus and including an annular stent, a rotatable membermounted to the stent, and a plurality of tissue engaging elements,wherein when the rotatable member is coupled to the control lead,rotating the control lead such that the rotatable member rotates in afirst direction results in radial expansion of the stent, and rotatingthe control lead such that the rotatable member rotates in a seconddirection results in radial compression of the stent, and wherein thetissue engaging elements are pivotable relative stent from a first stateto a second state, wherein in the first state, the tissue engagingelements are positioned so as to disengage native vascular tissue, andwherein in the second state, the tissue engaging elements extendoutwardly from the stent and are configured to engage the nativevascular tissue.
 18. The vascular system of claim 17, wherein theendovascular device further comprises a gear coupled to the stent, andwherein the rotatable member is a locking member configured toselectively couple the control lead to the gear, wherein the lockingmember is movable between an engaged configuration and a disengagedconfiguration, wherein in the engaged configuration, the locking membercontacts the gear, and the locking member and the gear rotate togetherwhen the control lead is rotated by the user, wherein in the disengagedconfiguration, the locking member is spaced from the gear and thelocking member rotates without rotating the gear when the control leadis rotated by the user.
 19. The vascular system of claim 18, furthercomprising sheathing extending radially outwardly from the stent,wherein the sheathing is configured to contact the native vasculartissue to reduce leakage between the native vascular tissue and thestent.
 20. The vascular system of claim 17, wherein the tissue engagingelements include tines with barbs.